Refractive Error - Myopia BilateralNCT05927753

Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens

A study testing Deseyne Daily Disposable Contact Lens (Test Device) in people with Refractive Error - Myopia Bilateral, run by Bruno Vision Care at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This clinical study is to provide clinical performance data comparing the test lens (Deseyne [vifilcon C] daily disposable soft contact lens) to a control lens (1-Day Acuvue Moist [etafilcon A] daily disposable soft contact lens) in the same indication for use (single use prior to removal followed by a fresh lens upon… Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Refractive Error - Myopia Bilateral
What is being tested?: Deseyne Daily Disposable Contact Lens (Test Device)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 3 sitesUnited States
Study dates: 8 Jun 2023to 8 Jan 2024
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18 to 40 years of age on the date the informed consent form (ICF) is signed
Presence of clear central corneas and absence of any anterior segment disorders in each eye
Presence of myopia and requirement for lens correction from -1.00 D to -6.00 D in each eye
Best-corrected distance visual acuity (BCDVA) of 50 ETDRS letters (0.1 logMAR) or better in each eye
Be an adapted soft contact lens wearer in each eye and agree to wear study lenses in each eye on a daily wear basis and not wear a non-study lens for approximately 3 months
Able and willing to comply with all treatment and follow-up/study procedures
Able to read, understand, and provide written informed consent on the IRB-approved ICF and provide authorization as appropriate for local privacy regulations

Who cannot join

Participation in any drug or device clinical investigation within 2 weeks prior to Screening and/or during the period of study participation
Women of childbearing potential (those who are not surgically sterilized or postmenopausal) who meet any of the following conditions:
Currently pregnant
Plans to become pregnant during the study
Currently breastfeeding
History of gas permeable lens wear in either eye within 30 days prior to Screening or history of polymethylmethacrylate lens wear in either eye within 3 months prior to Screening

Show all 30Show fewer

Current monovision, multifocal, or toric contact lens wear in either eye
In either eye, current nonabsorbable punctal plug or implantation of absorbable punctal plug within 2 to 6 months (depending on type of absorbable plug) prior to Screening, or punctal plug removal within 2 months prior to Screening. Permanent punctal occlusion in 1 or more puncta or nasolacrimal duct obstruction in either eye is excluded
Use of any prescription ocular medication throughout the duration of the study. Prescription eyedrops for dry eye disease (eg, Restasis, Xiidra, Cequa, Eysuvis), as well as nasally administered Tyrvaya, must be discontinued 2 weeks prior to Screening and are prohibited throughout the duration of the study Clinical Study Protocol Version 3.0, 26 April 2023 Page 17 of 66 Bruno Vision Care Protocol 22001
Use of over-the-counter eyedrops (eg, oxymetazoline, naphazoline, ketotifen, etc.), except for unpreserved lubricant eyedrops or artificial tears (eg, Systane, Refresh), within 1 week prior to Screening and throughout the duration of the study
Use of any systemic or topical medications that may, in the Investigator's opinion, affect ocular physiology or lens performance
Anisometropia (spherical equivalent) >2.00 D
Ocular astigmatism >1.00 D in either eye
Amblyopia in either eye
Aphakia in either eye
Active ocular disease (eg, dry eye disease, blepharitis, conjunctivitis, keratitis, etc.) in either eye. Subjects must be symptom free for at least 7 days
History or evidence of ocular infection within 30 days prior to Screening
History or evidence of ocular herpes simplex or ocular herpes zoster
Any grade corneal infiltrates in either eye
Grade ≥2 finding in either eye during slit lamp examination
Any "Present" finding in either eye during slit lamp examination that, in the Investigator's opinion, may interfere with contact lens wear
Any scar or neovascularization within the central 4 mm of the cornea in either eye. Subjects with minor peripheral corneal scarring (not extending into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible to participate in this study
History of any corneal surgery (eg, refractive surgery or therapeutic) in either eye
Any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study
Allergy to any component in the study care products
Meet any of the following criteria:
Subject is an employee of the investigative site
Subject or a member of the subject's household is an ophthalmologist, an optometrist, an optician, or an ophthalmic assistant/technician
Subject or a member of the subject's household is an employee of a manufacturer of contact lenses or contact lens care products
Subject or a member of the subject's household is an employee of a market research firm -

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Omega Vision Center PA
Longwood, Florida, 32779
Kennaar Eye Care
Pittsburg, Kansas, 66762
West Bay Eye Associates
Warwick, Rhode Island, 02888

Other trials in United States

About this study

Official title: A Randomized, Active-Controlled, Open-Label Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens

Read the detailed description

A multicenter, randomized, active-controlled, open-label study design will be used to compare the clinical performance of the Deseyne (vifilcon C) test soft contact lens to the similarly indicated 1-Day Acuvue® Moist® (etafilcon A) control soft contact lens.

Study participation is approximately 90 days in duration and will consist of approximately 80 subjects assigned in a 2:1 ratio to test or control lens bilaterally, respectively. Subjects must be otherwise healthy, with myopia between -1.00 D and -6.00 D and astigmatism no greater than 1.00 D that does not interfere with VA.

At the Screening Visit, approximately two-thirds of the eligible subjects will be randomized to receive the test lens (Deseyne [vifilcon C] lenses) and the other one-third eligible subjects will be randomized to receive the control lens (1-Day Acuvue Moist [etafilcon A] lenses). At the Dispensing Visit (Visit 2), subjects will be provided with test or control lenses as part of the dispensing package, along with instructions for the use and care of the lenses. They will be recommended unpreserved lubricating/rewetting solution for use as needed during the study.

Subjects will wear their assigned lenses bilaterally on a daily wear basis, for a minimum of 6 hours/day throughout the study (no maximum time is mandated, as long as subjects do not sleep in their lenses), with additional visits planned for 1 Week (Visit 3), 1 Month (Visit 4), 2 Months (Visit 5), and 3 Months/Exit Visit (Visit 6).

This study follows United States Food and Drug Administration (FDA) Premarket Notification 510(k) Guidance for Daily Wear Contact Lenses adopted in May 1994, and any unpublished subsequent policy declarations.

Conditions: Refractive Error - Myopia Bilateral
Being tested: Deseyne Daily Disposable Contact Lens (Test Device)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deseyne Daily Disposable Contact Lens (Test Device)Device
Comparison of contact lens performance between the test lens under study (Deseyne Daily Disposable Contact Lens) and the control lens f(1-Day Acuvue Moist Contact Lens) for safety and effectiveness.

Study groups in NCT05927753
Study group	Role	What they receive
Test lens. Deseyne Daily Disposable Contact Lens	Experimental	Test contact lens to be worn as a daily disposable soft (hydrophilic) contact lens, to be discarded daily. Individual new lens placed daily for a period of 90 consecutive days, bilaterally. Follow-up visits are 1 week, 1 month, 2 months, and 3 months after dispensing. Receives: Device: Deseyne Daily Disposable Contact Lens (Test Device)
Control lens. 1-Day Acuvue Moist Daily Disposable Contact Lens	Active comparator	Control lens to be worn as a daily disposable soft (hydrophilic) contact lens, to be discarded daily, Individual new lens placed daily for a period of 90 consecutive days, bilaterally. Follow-up visits are 1 week, 1 month, 2 months, and 3 months after dispensing. Receives: Device: Deseyne Daily Disposable Contact Lens (Test Device)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye
To assess each eye for the change from baseline to each post-baseline visit in distance logMAR VA (letters read)
Measured: Baseline, Day 1, Week 1, Month 1, Month 2, Month 3
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
To assess the number and percentage of subjects with no more than 5 letters read loss from baseline
Measured: Day 1, Week 1, Month 1, Month 2, Month 3
Slit Lamp Findings Grade >2 at Any Follow-Up Visit
To assess the following slit lamp findings: epithelial edema, epithelial microcysts, limbal injection, bulbar injection, upper lid tarsal conjunctival, corneal neovascularization, and corneal infiltrates
Measured: 3 months

Secondary outcomes (3)

Symptoms/Complaints
This unnamed questionnaire measures change from baseline in discomfort, excessive tearing, photophobia, halos, itching/burning/spectacle blur, variable vision, blurred vision, lens needs cleaning, handling using a 0 (no symptoms) to 4 (severe symptoms) scale for each symptom
Measured: Month 3
Lens Wettability, Centration, and Movement
Wettability Analog Scale 0-4 (0=100% wettable, 4=more than one dry spot greater than 0.5 mm) Lower score is better Centration Analog Scale 0-4 (0=superior cornea, 4=inferior cornea) Lower score is better Movement Analog Scale 0-4 (0=adequate, 4=adherence to cornea) Lower score is better
Measured: 3 months
Lens Deposits
To assess type of deposit
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 20238 Jan 2024

First posted3 Jul 2023
Study start8 Jun 2023
Primary completion8 Jan 2024
Study completion8 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Refractive Error - Myopia BilateralStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Comparison of a test contact lens performance to a known, cleared for market contact lens.
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05927753
Sponsor's protocol ID: BrunoVisionCare22001
Status last verified: Jun 2023
First submitted: 31 May 2023
Last updated: 2 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No